Regulatory Compliance

Digital Services

Offerings

Regulatory Affairs

Complying with global regulatory regimes is expensive and cumbersome, with stringent new regulations rolled out every year. Syntel has the infrastructure and experience to help life sciences companies maintain and manage compliance with a well-defined framework for system validation, and secure management of electronic records and signatures.

Our Services 

  • End-to-end document management
  • Publishing and submission services
  • Audits and validations
  • Computer system validation services
  • Labelling services

The Syntel Advantage

  • Integrated end-to-end record management and archival process
  • Experience in operations management in multiple geographies
  • Submission and audit-ready platforms
  • Dedicated CoE for regulatory affairs and compliance
  • Labelling conversion capabilities, including documentation review and translation
  • Expertise with marketing assets like brochures, newsletters, websites, motion graphics and rich media

Computer System Validation (CSV)

Increasing scrutiny by regulatory bodies and emphasis on product safety and effectiveness is putting pressure on life sciences companies to cost effectively reduce compliance and product recall risk. Syntel’s CSV solutions help our clients ensure that their systems operate with peak quality and efficiency to meet quality and regulatory requirements, while minimizing risk and legal costs.

Our Services 

  • End-to-end Computer System Validation services
  • Strategic compliance consulting
  • CSV Hands-on Services
  • IT infrastructure management

The Syntel Advantage

  • Integrated framework for continuous process improvement, quality assurance and compliance
  • Solutions for better ownership of quality and compliance services

Submission Publishing

The number of clinical documents required by regulatory agencies has increased dramatically with new drug safety guidelines. Syntel's publishing team is made up of doctors, life science experts, and technology experts ready to translate your complex data and results into formatted, regulatory compliant documents.

Our Services 

  • Document and module-level publishing
  • eCTD compilation and submission for IND, NDA, ANDA, CTA, MAA, DMF, SPL, and others
  • Submissions in electronic (eCTD, NeeS) and paper formats to FDA EU and other regulatory agencies
  • Dossier writing for Clinical Study Reports (Ph I-III), Safety Aggregate Reports (PBRER-PSUR, PADER,DSUR), Summary Documents, Clinical Overview, and CCDS 

The Syntel Advantage

  • Document, report and submission-level publishing management
  • Expertise in electronic submission standards, regulatory guidelines and compliance 
  • Intelligent process automation with the SyntBots automation platform
  • Operational cost optimization to manage peaks and valleys in your submission schedule

Regulatory IT Services

Syntel provides global regulatory IT services and lifecycle management for all phases of the pharmaceutical and medical device development process.

Our Services 

  • Clinical trial applications
  • Medical writing and dossier preparation
  • Change control management
  • Compliance and business risk consulting
  • Quality management and quality control
  • Regulatory and compliance management
  • Post-approval lifecycle management
  • Submission and data management

The Syntel Advantage

  • Expert team to manage adherence to regulatory requirements for pharmaceutical and medical product development programs
  • Consolidated framework for end-to-end pharmaceutical regulatory affairs, including dossier preparation, submission review and filing
  • Agile methodology to quickly implement revised plans as regulatory requirements change

Medical Device Regulation

The proposed EU MDR legislation represents an unprecedented regulatory change for the Medical Device sector. With a focus on clinical evidence, transparency, and traceability, it will impact areas such as Clinical, Regulatory, Manufacturing, Supply Chain, and Post Market Surveillance.

Our Services 

  • Medical Device Regulation (MDR) Consulting: Gap Analysis, Amendments/Re-certification, Implementation
  • Clinical and Post Market Clinical Follow-up (PMCF): R&D Consulting, Functional Services, CER Updates, and Vigilance
  • Quality Assurance: Quality Management System (QMS) Implementation, ISO 13485 Update, QSR 21 CFR 820, Risk Management ISO 14971, Corrective and preventive actions (CAPA), Compliance Support
  • New Product Development: Process Validation, Device Verification and Validation, Computer System Validation
  • Unique Device Identification (UDI) Compliance: Readiness Assessment, Implementation Support, Conversion Support
  • Labeling and Packaging: Labeling Analysis, Change Order, Artwork, UDI Compliance, Implant Cards  
  • Digital Modernization: IT Ops/DevOps, Process Automation, Big Data, Insights

The Syntel Advantage

  • Experience with top 20 medical device companies
  • Preferred partner for device engineering services
  • Labeling and packaging CoE
  • Global and local regulatory experience in multiple therapeutic areas
  • Clinical and PMS domain expertise

Identification of Medicinal Products (IDMP)

Life sciences companies are increasingly focusing on research and clinical R&D to deliver better products, resulting in an increase in R&D investments as well as checks and balances by regulatory agencies. Syntel helps clients significantly improve the existing operating framework for processes, practices and compliance.

Our Services 

  • Change management
  • Technology assessment
  • Database restructuring
  • Data collation and governance
  • Program management
  • Data analytics

The Syntel Advantage

  • Increase in patient safety parameters through better pharmacovigilance reporting
  • Enables regulatory agencies to make faster decisions with accurate and structured data, and oversight into the different stages of medicinal product lifecycles
  • Reliable, robust framework for medicinal product information exchange
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